"ART REGISTRY : Rheumatoid Arthritis and Anti-TNF"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Drug (anti TNF inhibitors) retention rate
研究概览
简要总结
Rheumatoid arthritis (RA) is a complex and multifactorial autoimmune disease. The biological treatments that are currently available for the treatment of RA are the TNF-alpha inhibitors. Tumor necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. The anti-TNFs were the first to enter the market, and they revolutionised the prognoses of patients with RA. They remain the most common first-line biotherapy and are the most used at this time.
The French Society of Rheumatologists intends to coordinate a prospective national registry study for this follow-up.
This registry will include 1500 RA patients from the start of treatment with anti-TNF-α and then followed for 5 years, regardless of the therapeutic modifications occurring thereafter.
This registry is an observational, multicentre, longitudinal, prospective registry study The objectives of this registry is to contribute 1) to evaluate the therapeutic management of patients; and 2) to improve this therapeutic management.
详细描述
Design: Observational, multicentre, longitudinal, prospective registry Primary objective: To evaluate the real life efficacy and safety of anti-TNF inhibitors in patients with RA using a prospective national registry.
Target population: Patients initiating anti-TNF therapy for RA (including infliximab, adalimumab, etanercept, certolizumab and golimumab, and their respective biosimilar according to their arrival on the market) Number of patients and centres : More than 80 centers in France (hospital-based, public and private practice) Recruitment period: 3 years Follow-up: 5 years
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with RA,
- •Patient in whom the specialist physician decides to start treatment with an anti-TNF drug, regardless of the treatment line and regardless of the anti-TNF, including infliximab, adalimumab, etanercept, certolizumab and golimumab, and their respective biosimilar according to their arrival on the market
- •Clinicians (hospital-based and private practice) who agree to adhere to the yearly renewal of the hospital prescription
排除标准
- •Patient already treated by the same anti-TNF in the past (same drug).
结局指标
主要结局
Drug (anti TNF inhibitors) retention rate
时间窗: From the beginning of the study until the end of the 5 years follow-up
Primary outcome will be 5-year drug retention, this rate will be compared between the different drugs to assess real life efficacy of anti-TNF inhibitors in patients with RA
次要结局
- Treatment retention rate on anti-TNF therapy(From the beginning of the study until the end of the 5 years follow-up)
- Number of patients receiving each of the drugs(From the beginning of the study until the end of the 5 years follow-up)
- - Number and nature of biologics previously received(From the beginning of the study until the end of the 5 years follow-up)
- rate of serious and opportunistic infections (overall and subtypes)(From the beginning of the study until the end of the 5 years follow-up)
- Rate of malignancies (overall and subtypes)(From the beginning of the study until the end of the 5 years follow-up)
- Rate of cardiovascular events (overall and subtypes)(From the beginning of the study until the end of the 5 years follow-up)
- rate of serious adverse events (overall and subtypes)(From the beginning of the study until the end of the 5 years follow-up)
- Rate of surgery and surgical complications (overall and subtypes)(From the beginning of the study until the end of the 5 years follow-up)
- Comparison with the other french biotherapy registries with similar methodology(From the beginning of the study until the end of the 5 years follow-up)
- Establishment of a database accessible to all participating clinicians in the collection for the purpose of making complementary analyses.(From the beginning of the study until the end of the 5 years follow-up)